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What does 510K clearance mean?

FDA clearance through the 510 (k) process means the agency is in agreement with the manufacturer that a medical device is similar to a previously approved product. In making that determination, the FDA will conclude a device is substantially equivalent to a marketed device if:

What is a 510 k medical device?

A 510 (k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92 (a) (3)) that is not subject to PMA.

What is 510 approval FDA?

A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513 (i) (1) (A) FD&C Act) that is not subject to premarket approval. Learn more...


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